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Bd Phoenix Automated Microbiology System-Cefoxitin-Gram Negative

by Becton, Dickinson & CO

510(k) K032567

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032567 Date17 Sep 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LON
Device Class
Class II
Regulation
21 CFR Part 866.1645
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD Phoenix Automated Microbiology System – Gram-Negative is an automated antimicrobial susceptibility testing device designed for rapid identification and susceptibility testing of gram-negative bacteria. It employs short incubation and automated detection methods to provide accurate antimicrobial resistance profiles, supporting clinical decision-making in microbiology laboratories.

This system is intended for use in clinical microbiology laboratories and is supplied as a reusable instrument with disposable consumables. It operates under sterile conditions and is classified as a Class II medical device under FDA regulations, with a 510(k) clearance. The system includes specific test panels, such as the cefoxitin panel for gram-negative bacteria, and adheres to regulatory standards for antimicrobial susceptibility testing.

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